Host Institution

Opportunities, competition and

freedom-to-operate for New Zealand

Dist. Prof. Harjinder Singh

Scanning the Horizon June 2016

search Food Regulations

Lynley Drummond

search Intellectual Property

Allan Main

search Industry Intelligence

Johnston Connelly

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Distinguished Professor Harjinder Singh

Professor Richard Archer

Dr Simon Loveday

Reports

Presentations

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Host Institution

Scanning the Horizon

Regulatory Workstream

Purpose of the Regulatory Workstream

To provide a roadmap of the regulatory environment and related topics for the HVN Platform Programmes in a user friendly format

KPI’s for the HVN Platform programmes include “regulator-approved evidence dossiers or dossiers submitted to FSANZ demonstrating consumer health benefits” by 2018

Deliverables

Regulatory Roadmaps:

– Clarity of requirements and processes for Platform Programmes to deliver on KPI’s

– Toolbox to assist programmes work through regulatory requirements

Case studies

Specific topic reports identified as valuable support to the HVN Programmes

HVN Target Jurisdictions Influencer Jurisdictions

Au /NZ South Korea European Union

China Indonesia FDA

Taiwan Philippines Canada

Hong Kong Malaysia Japan

Singapore India CODEX Alimentarius

Thailand Vietnam

Russia

Regulatory Roadmap

Interactive Roadmap developed

• Outlines key requirements for health claims which may be made across 17 regulatory jurisdictions

• Provides an overview of the procedures to make health claim applications

• Provides links to relevant legislation and guidance documents in each jurisdiction

• Copies of key documents provided country files accompanying the Roadmap

• Roadmap complements MPI “Global Regulatory Environment of Health Claims on Foods” document

Example of Roadmap – South Korea

> A set of 6 case studies were prepared to provide

examples of successful and unsuccessful health claim

applications in different regions

> The studies highlight:

– The level of research sitting behind applications and

health claim initiatives

• Human data, animal studies & in vitro studies

• Development of putative mechanisms

• IP background

– Timelines to develop the evidence base prior to

preparation of health claim applications

Case Studies

Case Studies

Claims Across Jurisdictions

• Consistency of information required – Characterisation of material and delivery

– Safety/toxicity

– “Dose”

– Putative mechanism (at least)

– Well designed human studies to demonstrate the health outcome

• Processes required for health claim registration varies

• Many countries have updated health claim regulations in the past 5-6 years and continue to amend. These changes have meant the requirements are more aligned across the regions

• Critical aspects to consider when

establishing evidence to support a food

health claim

– Clinical trial design

– Publication

– Links to and references key documents and

guidelines

• Detailed review of the new regulations and

requirements for China

• Update on the new health claim legislation

in Japan

Regulatory Report -Selected Topics

Scanning the Horizon

Industry Intelligence Workstream

Industry Intelligence

Monitoring emerging and growth trends in

markets

• Achieved through searching and monitoring databases,

literature, social media

– Mintel GNPD (Global New Products Database)

– New Nutrition Business

– Nutra-Ingredients

– Trade literature

– Company activity through press releases / social media

(Facebook / Twitter / Linkedin)

New Product Launches in the Food and

Beverages Categories

• Countries / Regions

• Functional Claims

• Ingredients

• Demographics

• Company

Bone Health Products for Seniors (+55)

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Taiwan

Indonesia

Italy

Japan

Argentina

France

UK

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Bone Health Products for Seniors (+55)

Ingredient Claim

Bone Health Products for Seniors (+55) Category

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Dairy BreakfastCereals

HotBeverages

OtherBeverages

ProcessedFish, Meat

& EggProducts

Sauces &Seasonings

Baby Food

Bone Health Products for Seniors (+55)

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Host Institution

Scanning the Horizon

Intellectual Property Workstream

IP Workstream: Purpose > Patent databases to inform research plans:

– Closer to market than science publications (supplement science

literature)

– Insights to

• technologies (established, emerging, trends ...)

• participants (key players, established and new; their tech strategy; possible

collaborators, rivals, targets...)

> Provides context to future commercialisation:

– IP risk to manage?

• Minefields – cluttered spaces with high FTO risk

• Goldmines – technologies and/or geographies with low patent densities

– Opportunities for own IP?

• Low patent density “white space” indicates potential IP opportunities

• Opportunity for zone-of-exclusion

– Freely available technologies

• Expired patents provide content free-for-public-use with assured FTO

Boundaries to Patent Research

> Three HVN themes, scope for each defined by the

health platform teams

– IMMUNE: oral interventions that offer ...

“enhanced influenza vaccine response; manage

irritant-driven respiratory inflammation”

– METABOLIC: oral interventions that offer ...

“metabolic syndrome management through targeting

the obesity link to diabetes and dyslipidaemia”

– ELITE GUT: oral interventions that offer ...

“avoiding gastrointestinal discomfort with irritable

bowel syndrome as a clinical target”

Boundaries to Patent Research (Contd)

> “Oral Interventions”

– Foods: primary target for HVN research opportunity

– Traditional Medicines: indicators of food-compatible

targets

– Oral Pharma: identify potential intervention biological

pathways to target

> “Research Tools”

– Biomarkers: individual biomarkers or biomarker

suites identified as response variables

– Research regimes: protocols for investigating

response to interventions

IP Workstream: Outputs

> A report for each theme focussing on INSIGHTS derived from

patents, patentees, and parallels (ie non-food aspects)

– Current food solutions;

– Technology trends over time;

– Key players;

– Approaches in non-food orals transferrable to food;

– Hot zones (minefields) and cold zones (goldmines)

> Around 100 pages each (additional appendices give patent

content detail):

– Proximity maps

– Text heat mapping

– Text networks

– Innovator activity clocks

– Player strategic profiles

Content Example: Proximity maps

In PROXIMITY LANDSCAPING patents

are organized based on their similarity

with one another.

• Each DOT locates a single patent family;

• Distance between two dots indicates

their similarity in content;

• Keywords (examples in call-outs plot) at

the geographic centre of all patents

aligned to that concept;

• Maps are drawn as contoured islands,

with concept density reflected as altitude;

• Useful to assess what are the hot topics

(and conversely empty spaces) in the

dataset.

Immune Report. Some impressions:

• Patent density around

ASTHMA/ALLERGY and

RESPIRATORY;

• Relatively vacant concepts are PRO-

IMMUNE NUTRITION and BIOACTIVES

SUPPORTING IMMUNITY

Asthma Allergy

Pharma Medicine

Food & Beverage Nutrition

Respiratory Influenza Viruses

Vaccinate Inoculate

Bioactive

Content Example: Text Heat Mapping

In TEXT HEAT MAPPING a further

dimension is added to the proximity map

by conducting text intensity analysis.

• Each BUBBLE locates a single patent

family;

• SIZE of the bubble correlates to the

frequency of the terms mined in that patent

text.

• Useful to assess what are the associations

between base concepts plotted on the

proximity map and specific ideas of interest

in the dataset.

Here we show the text intensity for

OBESITY terms in the METABOLIC

dataset taken from the Metabolic Report

. Some impressions:

• OBESITY is a strong target for Food &

Beverage , a moderate target for Oral

Pharma and weak target for Trad/Alt

medicine.

Food &

Beverage Oral Pharma

Trad & Alt

Medicine

Content Example: Mechanistic Clues

For this aspect we plot

BIOMECHANISM against the

CLINICAL TARGET with a bubble

graph where the size of the bubble

reflects the frequency of that

association.

Interplay between ORAL

PHARMA BIOMECHANISMS and

METABOLIC CLINICAL

TARGETS in a bubble graph

taken from the HVN Metabolic

Report provided to give

researchers some insights to

what biomechanisms may be

responsive to a food

intervention.

Content Example: Operator Strategy

PATENT PORTFOLIO STRATEGY PROFILE FOR LEADING OPERATORS across the full oral

intervention spectrum (Example for IMMUNE)

Defining a “BULL’S-EYE” PATENT

• Patents that most closely align with at

least one core interest of the HVN

Health Platform

• The set of published patents that:

• has the best potential to inform

research plans

• should be kept in sight for

managing freedom to operate risk

• Bull’s-eye patents are described in

the reports.

• Total bull’s-eye patents = 46 (8% of

eligible pool)

• Providing useful

FOOD INTERVENTIONS = 39

• For OBESITY = 27

• For DYSLIPIDAEMIA = 12

• Providing on-point

RESEARCH TOOLS = 7

• For OBESITY = 5

• For DYSLIPIDAEMIA = 2

METABOLIC BULL’S-EYE PATENTS

1. Gut Health – Industry Intelligence

2. Gut Health – Patent Landscape

3. Metabolic Health – Industry Intelligence

4. Metabolic Health – Patent Landscape

5. Immune Health – Industry Intelligence

6. Immune Health – Patent Landscape

7. Food-Health Relationship – Regulatory Overview

REPORTS

Patent Insights – IMMUNE

• Concept 1: Food interventions to enhance immune response to (flu) vaccination – Not totally new idea, 18 patents directed to this

– Broad range of actives cited as effective

– Oral actives included probiotics (x4), prebiotics (x2), specific peptides (x2), SCFA’s, CLA, particular lipids, glycosides, poly-gamma-glutamic acid, glucosamine, glucans, proteases, a specific mushroom and a kiwifruit extract (!!)

• Concept 2: Food interventions to cope with respiratory inflammation from environmental airborne irritants (incl asthma):

– Far less active, but not unknown with just 5 patents found

– Nestlé hold 2 of the set directed to immune enhancement with probiotic (for infants) and sialic acid prebiotic (for elderly)

– A third patent also combines pre- and probiotic for this effect

– The remaining patents claim peptides and Actinidia (kiwifruit, again) as actives

• Trad & Alt Med patents provide most explicit interventions for pollutant irritants : – Predominantly rely on food-acceptable extracts like gingko, kelp, liquorice, konjac, so should be

assessed for functional food use;

• Other points of note: – Infant immune stimulation patents far outweigh immune stimulation for adults and elderly

– Nestle (CH) with a portfolio of 26 patent families is the top patent filer across all sectors

– Other food companies with strong immune patent portfolios are Abbott (US, 8), Gervais Danone (FR, 8) & Mead Johnson (US, 7).

– Designing regulatory acceptable claim validation protocols for pollutant irritants will be a challenge as there seems to not yet be standard and recognised models to adopt “off the shelf”.

Patent Insights – METABOLIC

• Recent trend in focus of metabolics patents is away from obesity and lipid dysmetabolism to re-emphasise sugar dysmetabolism, esp serum glucose management.

– Rapid rise to 2005, then plateaued.

• Metabolic development hot-houses (by % first filings): – US (30%), JP (20%), CN (18%), KR (15%)

– EU only 5% first filings

• Sector focus: – Asian countries (JP, KR, CN) dominate food interventions and trad/alt med patent filings (mostly CN);

– Western countries dominate pharma filings

• Dominant food actives claimed as active against lipid dysmetabolic conditions – Natural extracts, esp saponins/polyphenols (rutin notable); protein-peptides-FAAs; lipids-phospholipids.

– Pre- & probiotics less impactful in this area

– Feedback from the Metabolic lead scientist that rutin was “a focus of interest” led to a report exclusively on rutin IP, particularly directed to management of metabolic hyperglycaemia.

– Rutin now a hot prospect for further study by science team for metabolic obesity management

• Key players – Nestlé (again) top of food league chart (12 patents), but 3rd overall and sole Western player of significance.

– Other strong food players are Kao Corp (JP), Fancl Corp (JP), Genmont Bio (TW), Kaneka (JP), Yakult Honsha (JP), Megmilk (JP)

– Asian (esp KR) universities strong too

Patent Insights – ELITE GUT

• Patent filing trend for foods targeting gut comfort conditions shows long-run growth – 10% sustained annual growth since 1999

• Balance shifting from pharma solutions to food solutions – Key pharma players Astrazenica, MSD, have retired from the field, whereas food cos have increased activity

• Innovation hot-houses (by % of first filings): – CN (27%); US (26%) neck-and-neck (but US wins quality stakes)

– Also rans are JP (12%); KR (7%) and EU (7%).

• Leading territories for gut comfort food innovations: – JP and EU each file well over 50% of their patents in the field as food sector solutions;

– US shows a lower proportion (ca 40%) but higher count.

• Dominant food actives claimed as active against gut discomfort – A heavy dominance of probiotics (present in 32% of relevant patents) and prebiotics (24%) in foods

promoting gut comfort; probiotics especially associated with foods for IBS

– Otherwise strong representations of protein-peptides-FAA’s (20%), Complex CHO’s (12%) and phytochemicals (12%)

– Insoluble fibre shows notably low presence; the focus has very much shifted to soluble fibre (Prebiotics).

• Key players: – Food companies show high presence in oral interventions to gut discomfort with top 4, and 6 of top 10 being

food companies

– Nestlé (CH) top dog (again) with 36 patent families, 4 times the count of runner-up Gervais Danone (FR)

– Ajinomoto (JP) and Nutricia (NE) make up the top 4 with Yakult Honsha (JP) and Ironwood (US) making top 10.